Drug factory · FDA FEI 3008798439
ECI Pharmaceuticals LLC
5311 NW 35th Terrace, Ft. Lauderdale, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 27, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2015: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Chlordiazepoxide and Clidinium | Makes it | Bi-Coastal Pharmaceutical Corporation | 42582-300 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 27, 2023 | Problems found, fixed voluntarily | Bioresearch Monitoring | 4 |
| Apr 22, 2022 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2019 | No problems found | Drug Quality Assurance | — |
| Nov 18, 2016 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | — |
| Nov 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2015 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | — |
| Feb 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 27, 2023 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, evaluation and reporting to FDA of post marketing adverse drug experiences. - Late submission of annual safety reports 21 CFR 314.80(c)(2)
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application. - Failure to maintain records 21 CFR 314.80(j)
You failed to maintain for a period of 10 years records of all adverse drug experiences known to you, including raw data and any correspondence. - Timely submission 21 CFR 314.81(b)(2)
An annual report was not submitted each year to the FDA division responsible for reviewing the application.
Registered with FDA for: analysis; label; manufacture; pack; repack.